1. Field of the Invention
This invention relates generally to a penile prosthesis for improved function and appearance, and more particularly to a penile implant for subcutaneous operation and a surgical implantation method therefor.
2. Description of the Related Art
The following art defines the present state of this field:
Finney, U.S. Pat. No. 4,204,530 discloses an implantable sleeve for increasing the penile diameter. The sleeve includes a flexible sheet of soft, physiologically acceptable implantable material, the sheet being of sufficient length when formed in the general shape of a cylindrical sleeve to extend from the glans penis to the base of the penis, and of a width which is insufficient to completely encircle the penis, but sufficient to cover the corpora cavernosa. The sheet preferably has edges which are rounded and tapered side edges. The sleeve also includes suturing strips on the inside wall of the sleeve, adjacent the side edges of the sheet, which facilitate the suturing of the sheet to the tunica albuginea. The sleeve further includes porous patches located on the interior of the inside wall of the sleeve into which fibroblasts from the underlying tissues can grow to further anchor the sleeve to the tunica albuginea. In the preferred embodiment, the sheet is of very soft, medical grade silicone elastomer, and suturing strips are of Dacron(tm) fabric and the porous patches are of Dacron(tm) fabric or fluff.
Yamanaka, U.S. Pat. No. 4,235,227 teaches an artificial corpus cavernosum device which is designed to be implanted into the impaired penis of a patient for the remedy of his impotence. The device is at least one artificial corpus cavemosum penis which comprises an elongated tubular pouch made of an artificial thin membrane to be implanted into the penis and for selectively receiving and being filled with a fluid for erecting the penis. The invention includes a container made of an artificial thin membrane for storing the fluid under the normal condition when the penis is not inflated. This container is implantable into the scrotum and is connected to the tubular pouch with a slenderized conduit means for connecting at least one artificial corpus cavemosum penis to the container means in fluid communication with one another. The tube has a check valve interposed in fluid communication with the container means, and having a valve member provided with a through-hole(s) for allowing the fluid, once forcibly delivered from the container means, to pass to the artificial corpus cavernosum penis and to return to the container means again little by little through the through-hole(s).
Rogers, U.S. Pat. No. 4,281,648 discloses an inflatable condom, prophylactic or prosthetic device having conventional anterior portion and retaining ring or reinforced edge with an expandable secondary portion extending from the anterior member, and having an air duct extending inside the anterior portion in communication with the secondary portion to facilitate controlled inflation of the secondary portion responsive to manipulation of a pressure bulb.
Trick, U.S. Pat. No. 4,369,771 discloses a simple, reliable pressure control valve for a medical device having a hydraulic system. The system is comprised of a valve housing having an open top and a bottom and an inwardly directed shoulder partially closing the top; a poppet with an upwardly extending stem mounted in the housing between the top and the bottom; a sealing edge mounted on the poppet circumferentially about the stem, and a calibrated spring urging the poppet towards the open top of the housing so that the sealing edge is in sealing contact with the underside of the shoulder and the stem extends above the top of the housing so that manual pressure can be exerted upon the stem to open the valve, or the valve can be opened by a hydraulic pressure which exerts sufficient force upon the top of the poppet to overcome the force of the spring.
Schroeder, U.S. Pat. No. 4,407,275 discloses a semi-rigid annular ring having individual expandable chambers on the internal wall that are distended separately by fluid pressure. A multi-port flexible conduit is connected to the ring, having individual ports for each chamber. Fluid pressure is supplied through the conduit manually by a bulb, or electrically by a pump through a circular valve plate allowing the chambers to expand and contract in linear sequence. When a penis is placed into the ring and fluid pressure is applied, blood is forced to the end of the organ through the successive expansion and contraction of the bellows in wave fashion mechanically creating an erect condition of the organ.
Yachia et al., U.S. Pat. No. 4,523,584 discloses a penile erectile system for treating male impotency. The system comprises a sleeve of biocompatible material having at least one pressurizable chamber which is adapted to be implanted about the penile shaft of a patient. A fluid reservoir of pressurizing fluid, and a pump for transferring the fluid under pressure from the reservoir to the chamber is placed beneath the penile skin, between the skin and the shaft. The system also includes tubing connecting the reservoir and pump to the pressurizable chamber, and a valve for controlling the flow of fluid into, and out of, the pressurizable chamber. In a preferred embodiment, a pressure bulb. serves both as the fluid reservoir and the pump.
Fischell, U.S. Pat. No. 4,628,912 describes a penile erection prosthesis that has a bellow-like adjustable root or tip extender that can be elongated or shortened by adding or deleting fluid from an internal chamber of the extender. By continuously adjusting the amount of fluid added or deleted, the length of the extender can be continuously adjusted. This adjustment can be made either during surgical implant or post-operatively by penetrating the skin with a non-coring needle and entering the extender to add or delete fluid. The length of the implant can be adjusted by adding or deleting fluid either from the root extender or from the tip end extender.
Whitehead, U.S. Pat. No. 4,665,903 teaches a prosthetic device for implantation within the penis which has a pumping mechanism that is integral with, and is in fluid communication with two fluid storage sections. Fluid is pumped manually from the proximal storage section to distal storage section and then to four distal expansile sections that inflate to render the penis rigid and capable of sexual activity. Undesirable shrinkage of the erect penis is avoided through a rigid frame and bellows that prevent the proximal reservoir from contracting longitudinally and radially as fluid is withdrawn from this storage section to produce the erect penis.
Trick et al., U.S. Pat. No. 4,726,360 discloses a penile prosthesis which is adapted to be surgically implanted in man for the treatment of erectile impotence. The prosthesis includes at least one elongated, flexible cylindrical member which is adapted to be implanted into the corpus cavernosum of the pendulous penis, a pressure bulb for pressurizing liquid, and tubing connecting the member and the bulb. The member includes an inner non-distensible pressure chamber and an outer distensible chamber. The two chambers are connected by a passage and a valve for controlling flow through the passage so that fluid can be transferred from the pressure bulb, via the pressure chamber, to the outer chamber to cause it to distend, and in turn increase penile girth.
Daly, U.S. Pat. No. 4,773,403 describes and improved penile prosthesis to be surgically implanted in man for the treatment or erectile impotence and includes at least one elongated, flexible cylinder containing therein a hydraulic system comprising a pressure chamber, a reservoir and a pump. It also includes an outer girth-adjusting chamber concentric with the pressure bulb located outside the cylinder so that the girth-adjusting chamber can be inflated and the girth of a penis increased by transferring fluid from the pressure bulb to the adjusting chamber.
Trick, U.S. Pat. No. 4,917,110 discloses an implantable prosthesis for correcting erectile impotence. The prosthesis includes at least one penile implant with a pressure chamber, an accumulator charged with fluid, tubing connected the accumulator to the pressure chamber of the implant, a valve which is normally closed, and a lever which can be moved to open the valve so that pressurizing fluid will flow from the accumulator into the pressure chamber.
Lue et al., U.S. Pat. No. 4,982,731 teaches a method and system for augmenting penile erection in a human male. An inflatable cuff is placed circumferentially around the corpora carvernosa, the deep dorsal vein, and the cavernous veins, adjacent to the hilum of the penis. Selective compression of the cuff will function to restrict venous drainage to augment penile erection. The cuff is adapted to have opposite ends thereof attached together and at least one inflatable vesicle is formed on the inner side of the cuff. A pump, including an attendant control system, is sized for implantation in a scrotum whereby the pump can be selectively squeezed to inflate and fluid pressurize the vesicle to compress the cuff around the penis. A control circuit, connected between the cuff and the pump, functions to automatically deflate the cuff after a predetermined period of time has elapsed.
Zinner et al., U.S. Pat. No. 5,069,201 teaches a penile prosthesis which includes proximal and distal end portions with an intermediate normally flexible, nondistensible, collapsible main body portion that adjoins the proximal and distal portions. The main body portion includes filler elements that, in some embodiments of the invention, limit radial expansion of a rigidification chamber of the main body portion, and in other embodiments, limit radial constriction of the rigidification chamber. In some embodiments of the invention, rigidification is accomplished by movement of fluid into a rigidification chamber and in other embodiments of the invention rigidification is accomplished by movement of fluid out of a rigidification chamber. The prosthesis includes a manually maniputable pumping arrangement to establish the necessary fluid movement for development of an erectile condition or a flaccid condition as desired.
Trick, U.S. Pat. No. 5,101,813 discloses a sterile, fully assembled, multi-component, penile erectile system which is to be surgically implanted in man for the treatment of erectile impotence. The system includes at least one elongated, flexible cylindrical member with a pressure chamber for implanting into the pendulous penis; a pressure bulb to be implanted in the scrotal sac; tubing integrally connecting the pressure chamber and the bulb to form a closed system; and, a system for adding or subtracting fluid from the system. The tubing is reinforced so that it will not collapse under suction or kink when bent. In one embodiment the pressure bulb is a multi-stroke pump and in another embodiment there is a receptacle for storing any tubing in excess of that required to extend between two or more components in a given patient. A method of sterilizing and packaging the system so that it can be provided to a surgeon assembled, filled and sterile is also described.
Elist, U.S. Pat. No. 5,445,594 teaches an implant device for expanding the girth and length of a penis. A soft, flexible body is implanted between the shaft and the skin of the penis. The body takes the shape of a partial cylindrical sleeve that has an outer, relatively elastic sheet member and an inner, relatively inelastic sheet member. When implanted, the body covers the corpus cavernosum of the penis and does not or only partially covers the urethra, and extends in length between the glans penis and the base of the penis. A principally closed sack is formed between the inner and outer sheet members for receiving a fluid under pressure from a fluid source. Spring-like ribs are embedded within the inner sheet member for preventing collapse of the inner sheet member when the body is deflated.
The prior art teaches devices which can be implanted to replace a damaged corpus cavernosum. The prior art also teaches devices to treat impotency, as well as sheaths which can be fitted around a penis to augment size. However, the prior art does not teach a prosthesis which can be implanted to increase the length and girth of the penis while maintaining a smooth, natural look and feel, both while flaccid and while inflated. The present invention fulfills these needs and provides further related advantages as described in the following summary.